Kornimate/medical-research-clean huggingface dataset:
metabolic tumor volumes in radiation treatment of primary brain tumors

Conditions: Brain Tumor; Glioblastoma Multiforme

Summary: * metabolic tumor volume (mtv), identified by magnetic resonance spectroscopic imaging (mrsi) is different from the clinical target volume (ctv) used for radiation dose delivery in the treatment of brain tumors. * if mtv \> ctv, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. furthermore, in case of local recurrence, the lesion is located in the mtv area that is outside of the ctv. * alternatively, if ctv \> mtv, then the difference in volumes is related to higher treatment toxicity.

metabolic tumor volume (mtv), identified by magnetic resonance spectroscopic imaging (mrsi) is different from the clinical target volume (ctv) used for radiation dose delivery in the treatment of brain tumors. * if mtv \> ctv, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. furthermore, in case of local recurrence, the lesion is located in the mtv area that is outside of the ctv. * alternatively, if ctv \> mtv, then the difference in volumes is related to higher treatment toxicity.

Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed primary brain tumor. * patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors. * patients must be 18 years or older. * patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing mri/mrs exam * patients who do not suffer from claustrophobia (fear of enclosed spaces) * karnofsky performance status ≥ 60. * patients whose size would allow them to fit into the bore of the mri instrument. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients younger than 18 years. * inability to undergo mri/mrs exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. claustrophobia (fear of enclosed spaces). * karnofsky performance status \< 60. * patients too large (\> 300 lbs.) to fit into the bore of the mri instrument. * inability to understand the informed consent document.

Keywords: brain tumor glioblastoma multiforme gbm metabolic tumor volume mtv clinical tumor volume ctv
tobacco impact on quality of life on snus-use, dual use, smoke use and non-using.

Conditions: Tobacco Use

Summary: the primary aim of this study was to compare hrqol in snus-users and dual users (snus and smoking) with never tobacco users. secondary aim included comparing hrqol in smokers with non-smokers.

tobacco use is a major public health issue. the number of smokers decrease simultaneously as oral moist snuff (called "snus"), is promoted as a healthier alternative in spite its' negative health effects. studies of health-related quality of life (hrqol) of those who use snuff are lacking. recruitment of 674 women and 605 men aged 18 to 65 years through a swedish population data-base was performed for this cross-sectional study in southwestern sweden. subjects completed a questionnaire about tobacco use and the 36-item short form health survey (sf-36). the non-parametric mann-whitney test was used for statistical analysis.

Eligibility criteria:
inclusion criteria: age 18 to 65 years exclusion criteria: not understand the swedish language

Keywords: cigarette smoking health population characteristics quality of life tobacco smokeless.
inhaled lavender applied at hemodialysis patients and effect on pain, comfort, and anxiety

Conditions: Hemodialysis

Summary: the procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. however, patients tolerate needle insertion more easily when the pain is managed well. therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (hd), and to facilitate patient's compliance to treatment over a longer period. being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.

experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. therefore, pain control is an important priority in these patients. in this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * on maintenance hemodialysis three times per week for four hours per session * receiving hemodialysis therapy for a least six moths at the time of the study * having the ability to smell * able to communicate in turkish * willing to participate to the study exclusion criteria: * 18 years of age younger * absence of psychiatric disorders that cause cognitive dysfunction, such as alzheimer's disease or chronic psychosis * pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases * administered with painkillers in the past 3 hours * having infection at the fistula area * requiring more than one attempt for fistula puncturing * unwilling to to participate to the study
switch - sensing with insulin pump therapy to control hba1c

Conditions: Diabetes Mellitus, Type 1

Summary: the primary objective of this study is to evaluate whether the patients with type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the medtronic minimed paradigm® real-time pump system with continuous glucose monitoring versus the medtronic minimed paradigm® real-time pump alone with self monitoring blood glucose (smbg).our null hypothesis is there is a 0% reduction in hba1c from baseline compared to control group, after 6 months of treatment.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent, * sub-optimal glycemic control (7.5%\<hba1c\<9.5%). * patient treated by continuous subcutaneous insulin infusion (csii) for at least 6 months prior signature of informed consent. * patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent. * patient has no preliminary experience with the sensor function of the paradigm real-time or the guardian® real-time for the 4 months prior signature of informed consent. exclusion criteria: * existing pregnancy or intention to conceive (as assessed by investigator). * hearing or vision impairment so that glucose display and alarms cannot be recognized. * three or more incidents in the last 12 months of severe hypoglycaemia with documented blood glucose below 50mg/dl (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar. * history of hypoglycemic unawareness as assessed by the investigator. * alcohol or drug abuse, other than nicotine. * documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.). * any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, crohn's disease, ulcerative colitis, mb addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : body mass index \>35 and children body mass index \> 2 standard deviations. for age) as assessed by the investigator. * any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures. * for pediatric subjects: does not have a reliable support person. * plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places). * participation in another clinical study, on-going or completed less than 3 months prior to signature of patient informed consent.

Keywords: type 1 diabetes
prevention of the procedural pain in the newborn

Conditions: Prevention of the Procedural Pain in the Newborn

Summary: the aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (nirs)

many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. however slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Eligibility criteria:
inclusion criteria: * gestationnel age included between 37 and 42 weeks * born in the chru of brest * breast-fed * score of apgar upper to 7 * no pathology malformative * absence of known chromosomal abnormality * consent of parents exclusion criteria: * maternal drug use * morphinic treatment * barbiturate treatment * benzodiazépine treatment

Keywords: breast-feeding saccharose breast-feeding newborn cortical pain responses near infrared spectroscopy (nirs) salivary rate cortisol heel lance
the effects of a weight management program on body weight and quality of life

Conditions: Overweight; Obesity

Summary: evaluate the impact of a 12-week behavioral weight management program on body weight and quality of life. we hypothesize that participants will lose body weight and see improved quality of life after program completion.

this study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. findings from this study will also help with program development and improvement within our center. the already established weight management program is called healthy habits for life (hhl) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions). all patients who are enrolled in the healthy habits for life group program at the weight center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. at this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the iwqol-lite quality of life questionnaire. after completion of the 12 hhl group sessions, all patients at the weight center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. at this visit, subjects participating in the research study will again be provided with the iwqol-lite questionnaire to fill out.

Eligibility criteria:
inclusion criteria: * english speaking adults aged 18 or older * bmi ≥ 25 * enrolled in hhl program at the mgh weight center exclusion criteria: * non-english speaking patients
acute appendicitis in foreign workers of northern israel

Conditions: Surgery

Summary: to compare the outcome to acute appendicitis in foreign workers to the native patients.

this is a retrospective case-control study. the investigators identified all patients aged 18-50 who were admitted to our institution between january 1st, 2013 and october 31st, 2018, with the diagnosis of acute appendicitis. the study group included all foreign workers and the control group was age, sex, and co-morbidities matched group from the local population. the investigators compared time to presentation, admission parameters and disease outcomes.

Eligibility criteria:
inclusion criteria: * patients aged 18-50 who were admitted to our institution between january 1st, 2013 and october 31st, 2018, with the diagnosis of acute appendicitis exclusion criteria: * pregnant women * patient whose pathology report of the appendix was normal

Keywords: acute appendicitis foreign workers complicated appendicitis
tachocomb s versus standard surgical treatment in surgical resection of renal tumour (tc-015-in)

Conditions: Surgical Resection of Superficial Renal Tumour

Summary: the overall objective is to compare efficacy and safety of tachocomb s and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.


Eligibility criteria:
inclusion criteria: patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. after the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained. exclusion criteria: patients undergoing an emergency operation, or with more than one tumour will be excluded. patients with a clinically abnormal value of prothrombin time or activated partial thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen will be excluded. in case the tumour was resected by use of a laser scalpel, infrared coagulator or argon beamer and if any fibrin glue haemostatic was used before randomisation the patient will be excluded from the trial. furthermore, patients will be excluded if extensive resection/extirpation of the kidney become necessary or in case of serious surgical complication occurring during the operation.
a phase 2 efficacy and safety study of dapirolizumab pegol (dzp) in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: the purpose is to evaluate the efficacy and safety of three different doses of dapirolizumab pegol (dzp) versus placebo in adult subjects with moderately to severely active systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of systemic lupus erythematosus (sle) confirmed by systemic lupus international collaborating clinics (slicc) classification criteria * moderate to severe sle disease activity * evidence for at least 1 of the following sle markers: * anti-dsdna antibodies confirmed by central laboratory or * low complement confirmed by central laboratory or * antinuclear antibody (ana) titer of \>= 1:80 in combination with at least 1 of the following: historical positivity for anti-dsdna or positivity for extractable nuclear antigen (anti-ena) confirmed by central laboratory * the subject is receiving stable sle standard-of-care medication exclusion criteria: * mixed connective tissue disease, scleroderma, and/or overlap syndromes of sle * subjects with severe neuropsychiatric sle or other neurological symptoms that in the opinion of the investigator, would prevent the subject from completing protocol required procedures and assessments. * new or worsening class iii or iv lupus nephritis * chronic kidney failure stage 3b * evidence of human immunodeficiency virus (hiv) infection, agammaglobulinemias, t-cell deficiencies, or human t-cell lymphotropic virus-1 infection at any time prior to or during the study * clinically significant active or latent infection (eg. chronic viral hepatitis b or c) * known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tb (ltb) infection * live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug * history of thromboembolic events within 12 months of screening * subject has used protocol defined prohibited medications

Keywords: systemic lupus erythematosus (sle) dapirolizumab pegol (dzp)
study of neuroplasticity on depressed patients : modulation of mep induced by theta burst stimulation

Conditions: Depression

Summary: neuroplasticity is supposed to be altered in patients suffering from a major depressive disorder (mdd). transcranial magnetic stimulation is a medical device which measures cerebral plasticity. several parameters of cortical excitability are available for that purpose. these parameters are altered on patients wth mdd and these modifications are corrected after treatment. therefore results in the studies are very heterogeneous. theta burst stimulation (tbs) is a type a transcranial magnetic stimulation (tms) protocol and can induce cerebral plasticity. the cerebral plasticity induced by tbs was measured on a group of patients suffering from asperger's disease (asd) versus a control group. the plasticity was significantly different in patients with asd. the aim of our study is to study the neuroplasticity induced by tbs on a patients with mdd.

the study is lead with patients suffering from a mdd. all patients are drug free. patients are compared to a control group of healthy subjects the protocol has 2 sessions. during the first session, after determining the parameters of stimulation (stimulated target : part of the left motor cortex responsible for the contraction of the right first dorsal interosseous muscle ; activity motor threshold (amt) ; intensity of stimulation providing a motor evoked potential (mep) with an amplitude of 1mv (mep 1mv)), a baseline consisting of 15 mep (intensity mep 1mv) is measured. then each subjet receive a tbs protocol (ctbs or itbs) (intensity of stimulation 80% of amt). after receiving the stimulation, sets containing 10 mep are regularly measured by each subject. during a second session, the same protocol is done again with the other tbs stimulation (ctbs or itbs) the subject didn't get during the first session. a neuronavigation device is used to determine precisely the area of stimulation.

Eligibility criteria:
inclusion criteria: subjects with mdd * mdd according to definition provided by the dsm v * no antidepressant healthy controls * no present psychiatric disease exclusion criteria: * depression with melancholic features * pregnancy * contra indication in the use of tms (personal history of epilepsy, deep brain stimulation, vague nerve stimulation, pace maker, intracerebral lesion, pieces of metal inside of the brain) * diseases with neurological effects (multiple sclerosis, parkinson disease, hiv...)

Keywords: theta burst stimulation
treatment after progression of fulvestrant among metastatic breast cancer patients

Conditions: Breast Cancer

Summary: what comes after fulvestrant? a real world multicenter retrospective study-treatment after progression of fulvestrant among metastatic breast cancer patients in china.

there is no evidence of treatment after progression of ful. we retrospectively evaluated hr+, her2- mbc patients failed on ful 500mg as first line or second line therapy from 2014 to 2017 in 6 institutions. treatment pattern, pfs, os and safety were analyzed to figure out the situation and efficacy of treatment after fulvestrant.

Eligibility criteria:
inclusion criteria: * patients who were treated with fulvestrant between june 2014 to june 2017 as first line or second line therapy * patients received subsequent treatment after progressing on fulvestrant for at least one cycle (\>1 month) * complete medical history was available exclusion criteria: * subsequent treatment was not standard therapy (cannot be classified into endocrine therapy/ chemotherapy) * medical history was incomplete

Keywords: fulvestrant progression endocrine sensitivity
clinical trial comparing tace with tace + sabr in stage bclc b hcc (hepstar)

Conditions: Liver Neoplasms; Hepatocellular Cancer

Summary: this will be multicentre a phase ii randomized controlled and open-label trial. it will compare the 6-months objective response (cr+pr) rates obtained with drug eluting bead trans-arterial chemo-embolization (deb-tace) alone versus deb-tace followed by stereotactic ablative radiotherapy (sabr) in patients with hepatocarcinoma stage bclc b. this trial will also include one substudy. this substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (mri) results. every patient participating to the trial can also participate to this substudy.

the patients will be randomized in 2 arms determining the treatment they will receive: arm a: actual standard treatment = tace arm b: experimental arm = tace + sabr

Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by: * dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out * histopathology * satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable * hepatocellular carcinoma belonging to barcelona clinic liver cancer stage system class b * tumor must be measurable on a multi-phase mri according to mrecist criteria * non-tumoral liver volume ≥ 800 cc * child-pugh (cp) a to b7 cirrhosis * hcc patients can be included if they require treatment prior to liver transplantation * ecog performance status 0-1 * ast/alt \< 5 times uln * initial platelets ≥ 50 000 x 10e9/l, neutrophils \> 1500 x 10e9/l, hb \> 9 g/dl * serum creatinine \< 1.5 x normal, or calculated creatinine clearance rate ≥ 60 ml/min * as tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. cholangiocarcinoma cannot be included. * written informed consent form to be signed, * patient willing and able to comply to the follow-up schedule * patients in fertile age should use a contraceptive method during treatment and 4 months after. exclusion criteria: * eligibility for resection or ablative treatments * extra hepatic spread of the disease * previous treatment of the same lesion with tace * previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen * uncontrolled ascites * uncontrolled encephalopathy * any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required) * known current pregnancy * uncontrolled active co-morbidity

Keywords: hepatocellular cancer stereotactic body radiotherapy chemoembolization, therapeutic